Medegen Receives FDA Clearance for MaxGuard(TM) Advanced Luer-Activated Device with Antimicrobial Technology

First Positive Displacement Needleless Connector with Antimicrobial Technology

Ontario, Calif., January 8, 2009 - (HSMN NewsFeed) — Medegen, a leading innovator in infusion therapy products, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new MaxGuard(TM) Advanced Luer Activated Device featuring Agion® Antimicrobial Technology. MaxGuard is the first positive displacement needleless connector featuring impregnation of the antimicrobial additive into each of the components of the device. Laboratory testing has demonstrated this new antimicrobial device exhibits a kill rate of greater than 99.99 percent representing a 4+ log reduction on infection-causing organisms predominantly responsible for catheter related bloodstream infections.

Full text >>